Status:
RECRUITING
LIRRH Trial for the Right-sided Colon Cancer
Lead Sponsor:
Chaoxi Zhou
Conditions:
Ascending Colon Cancer
Proximal Transverse Colon Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this clinical trial is to compare the short- and long-term outcomes of laparoscopic ileocecal reconstruction right hemicolectomy (LIRRH) with those of traditional laparoscopic right hemicol...
Detailed Description
This is a prospective, single-center, open-label, randomized controlled clinical trial. Eligible patients will be randomly assigned (1:1) to undergo either LIRRH or TRH and will receive the correspond...
Eligibility Criteria
Inclusion
- Age 18-75 years
- ASA physical status ≤ III
- Endoscopy and biopsy-proven colon adenocarcinoma
- Contrast-enhanced abdominal CT showing primary tumor located in the ascending colon or proximal transverse colon (proximal one-third)
- Pre-operative clinical stage: TanyNanyM0
- Able to understand the study protocol, willing to participate, and provide written informed consent
Exclusion
- History of hypertensive crisis or hypertensive encephalopathy.
- Severe cardiopulmonary insufficiency or any other contraindication to surgery.
- Uncorrectable electrolyte disturbances (e.g., potassium, calcium, magnesium).
- Evidence of significant bleeding diathesis or high hemorrhagic risk:
- Prior intracranial or intraspinal hemorrhage.
- Tumor invading major vessels with obvious bleeding risk.
- Thrombotic or embolic event within 6 months before study treatment, or significant vascular disease (e.g., surgical-repair aortic aneurysm).
- Clinically relevant hemoptysis or tumor bleeding of any cause within 1 month before screening.
- Therapeutic-dose anticoagulation within 2 weeks before study treatment (except low-molecular-weight heparin).
- Antiplatelet therapy within 10 days before study treatment (e.g., aspirin \> 325 mg/day, clopidogrel \> 75 mg/day, dipyridamole, ticlopidine, cilostazol).
- Active tuberculosis.
- Any active autoimmune disease or history of autoimmune disease with expected recurrence (including but not limited to SLE, RA, autoimmune hepatitis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyper- or hypothyroidism, asthma requiring bronchodilators).
- Pre-operative evidence of synchronous multiple primary colorectal cancers or other conditions requiring additional bowel resection.
- Pre-operative imaging or intra-operative findings showing:
- Tumor infiltration into adjacent organs requiring multi-visceral resection;
- Distant metastasis;
- Unresectable (unable to achieve R0) disease.
- Other malignancies within the past 5 years, or familial adenomatous polyposis; except cured carcinoma in situ of the cervix, basal-cell carcinoma, papillary thyroid carcinoma, or cutaneous squamous-cell carcinoma.
- Intestinal obstruction, perforation, or bleeding requiring emergency surgery.
- Patient unsuitable or unable to tolerate laparoscopic surgery.
- Pregnant or lactating women.
- History of psychiatric disorders precluding compliance.
- Prior neoadjuvant therapy.
- Multidisciplinary team (MDT) decision that the patient is not appropriate for the study.
- Patient unable to understand the study conditions/objectives and refuses to give informed consent.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 28 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07207317
Start Date
May 1 2025
End Date
April 28 2028
Last Update
October 3 2025
Active Locations (1)
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1
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000